This week, the most noteworthy event is Eli Lilly's hypoglycemic drug tirzepatide, a GIP/GLP-1 double agonist, was declared for marketing in China. The news review of this week is from September 5 to 9, covering a total of 25 pieces of information in 3 sections, i.e., drug review, R&D, and business.
Drug Review
NMPA – Marketing
[Application]
1. On September 6, the CDE official website revealed that the marketing application of Biohaven's Rimegepant had been accepted, and its indication is speculated as the acute migraine of adults. Rimegepant, an oral CGRP receptor antagonist, has been approved by the FDA for the treatment of acute migraine and episodic migraine in adults. In May 2022, Pfizer acquired Biohaven with approximately US$ 11.6 billion and obtained Rimegepant.
2. On September 7, the CDE official website revealed that the marketing application of Eli Lilly's Tirzepatide had been accepted for the improvement of the blood sugar control of adult type 2 diabetic patients. Tirzepatide, approved for marketing by the FDA in May 2022, is a weekly injected GIP and GLP-1 receptor agonist which integrates the effects of two incretin into a new molecule. It also possesses a significant effect on losing weight.
3. On September 8, the CDE official website revealed that the marketing application of Stone Pharma’s PD-L1 antibody, Sugemalimab injection had been accepted. It is intended to be used for the single-drug treatment of relapsed or refractory extranodal natural killer/T cell lymphoma (R/RENKTL). In October 2020, Sugemalimab was recognized by the FDA as a breakthrough therapy for this indication. No PD-1 or PD-L1 antibody has been approved for the treatment of R/RENKTL at present.
NMPA – Clinical Trials
[Approval]
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